510(k) · Cleared
ClearedInfinity Monitors with Scio Modifications
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jul 20, 2005 as substantially equivalent to K031340 (Siemens Medical Solutions USA, Inc., 2003) and 3 other predicates after a 30-day review. Its family tree reaches back 6 generations to 1995. 230 later devices descend from it.
- Decided
- Jul 20, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K946306 (1995). 34 ancestors in all, the oldest K844187 (1985). 230 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 5 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 4 generations backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 3 generations backK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
- 2 generations backK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
- 1 generation backK040188 Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004
- This deviceK051628 Infinity Monitors with Scio ModificationsDraeger Medical Systems, Inc. · 2005
- Descendant · cites it directly · 222 of its ownK053204 Intellivue Gas Modules, Models G5 M1019A and G1 M1013ADraeger Medical AG & Co. Kgaa · 2006
- Descendant · 2 generations on · 221 of its ownK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- Descendant · 3 generations on · 211 of its ownK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- Descendant · 3 generations on · 188 of its ownK062283 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90…Philips Medical Systems North America, Inc. · 2006
- Descendant · 3 generations on · 176 of its ownK062392 Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006
Showing 5 of 230 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 230 · See all- K053204Intellivue Gas Modules, Models G5 M1019A and G1 M1013ADraeger Medical AG & Co. Kgaa · 2006 · cites it directly222descendants
- K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2006 · 2 generations on221descendants
- K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 2006 · 3 generations on211descendants
- K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc. · 2006 · 3 generations on188descendants
- K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006 · 3 generations on176descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −5 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −4 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −3 | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &… | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −2 | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with… | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −1 | K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas Module | Draeger Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K051628 | Infinity Monitors with Scio Modifications | Draeger Medical Systems, Inc. | 2005 | — |
| +1 | K053204 | Intellivue Gas Modules, Models G5 M1019A and G1 M1013A | Draeger Medical AG & Co. Kgaa | 2006 | — |
| +2 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| +3 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| +3 | K062283 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient… | Philips Medical Systems North America, Inc. | 2006 | — |
| +3 | K062392 | Philips MP5 Intellivue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 8 | 0 |
| 2012 | 10 | 0 |
| 2013 | 11 | 0 |
| 2014 | 9 | 0 |
| 2015 | 8 | 0 |
| 2016 | 9 | 0 |
| 2017 | 11 | 0 |
| 2018 | 13 | 0 |
| 2019 | 9 | 0 |
| 2020 | 9 | 0 |
| 2021 | 14 | 0 |
| 2022 | 19 | 0 |
| 2023 | 21 | 0 |
| 2024 | 18 | 0 |
| 2025 | 21 | 0 |
| 2026 | 14 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSummary page 1…uced. These devices will connect to an R50 Bedside recorder, either directly or via the Infinity Network. Predicate Devices: Infinity Monitors with Scio: 5 10(k) K(031340, K033957, K0401 88 Varmos: K(040847 Substantial Equivalence: Scio with sample gas return was tested in accordance with i… | 2003 |
| * | K033957 | Infinity Modular Monitors VF4 Modifications with Scio, Models Delta, Delta XL, Kappa, SC…Summary page 1…ese devices will connect to an R50 Bedside recorder, either directly or via the Infinity Network. Predicate Devices: Infinity Monitors with Scio: 5 10(k) K(031340, K033957, K0401 88 Varmos: K(040847 Substantial Equivalence: Scio with sample gas return was tested in accordance with internal d… | 2004 |
| * | K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleSummary page 1…es will connect to an R50 Bedside recorder, either directly or via the Infinity Network. Predicate Devices: Infinity Monitors with Scio: 5 10(k) K(031340, K033957, K0401 88 Varmos: K(040847 Substantial Equivalence: Scio with sample gas return was tested in accordance with internal design con-… | 2004 |
| * | K040847 | Modification to Vamos Anesthetic Gas MonitorSummary page 1…with Draeger Medical Systems' Infinity monitors. The modifi- cation is the addition of a sample gas return kit identifical to that of Draeger Medical's Varnos, 5 10(k) K(040847. The modification allows the user the option of returning the sample gas from the Scio gas module to the breathing circuit. Inte… | 2004 |
What descends from it? (230)
See all 2302 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 34 ancestors has a recall of any class.
- Of its descendants, K053204 (Draeger Medical AG & Co. Kgaa, 2006) has gone furthest, with 222 descendants of its own.
- 5 other devices also cite its predicate K031340.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The INFINITY Modular monitors are capable of monitoring: * Heart rate * Respiration rate * Invasive pressure * Non-invasive pressure * Arrhythmia * Temperature * Cardiac output * Arterial oxygen saturation • Pulse rate * Apnea * ST Segment Analysis * 12-Lead ST Segment Analysis * tcpO2/tcpCO2 * EEG signals * FiO2 The Scio module samples breathing gases from adults and pediatrics. The gas modules continuously measure the content of C02, N20, 02 and one of…
Read the full statement (266 words)
The INFINITY Modular monitors are capable of monitoring:
* Heart rate
* Respiration rate
* Invasive pressure
* Non-invasive pressure
* Arrhythmia
* Temperature
* Cardiac output
* Arterial oxygen saturation
• Pulse rate
* Apnea
* ST Segment Analysis
* 12-Lead ST Segment Analysis
* tcpO2/tcpCO2
* EEG signals
* FiO2
The Scio module samples breathing gases from adults and pediatrics. The gas modules continuously measure the content of C02, N20, 02 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane and Desfiurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.
With etCO2 the monitors gar measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2±Respiratory Mechanics, Spirometry and carbon dioxide can be monitored.
The monitors can interface with specific third party devices via an MIB protocol converter.
The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; anti tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.
MRI Compatibility Statement:
The INFINITY Modular Monitors are not compatible for use in a MRI magnetic field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051628: Infinity Monitors with Scio Modifications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051628
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026